BRPI0416109A - processo para preparação de composições de clopidogrel - Google Patents

processo para preparação de composições de clopidogrel

Info

Publication number
BRPI0416109A
BRPI0416109A BRPI0416109-2A BRPI0416109A BRPI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A
Authority
BR
Brazil
Prior art keywords
clopidogrel
granules
particles
aggregates
preparing
Prior art date
Application number
BRPI0416109-2A
Other languages
English (en)
Inventor
Ramaswami Bharatrajan
Pallavi Kharkar
Sunil Roy
Original Assignee
Sandoz Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sandoz Ag filed Critical Sandoz Ag
Publication of BRPI0416109A publication Critical patent/BRPI0416109A/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

"PROCESSO PARA PREPARAçãO DE COMPOSIçõES DE CLOPIDOGREL". Esta invenção refere-se a uma composição adequada para administração oral, compreendendo clopidogrel em forma de sal farmaceuticamente aceitável, essa composição compreendendo: um revestimento polimérico selecionado em um acetato de polivinila ou um álcool polivinílico, e um componente hidrofóbico compreendendo um óleo vegetal hidrogenado, em que o sal é selecionado em mesilato, bromidrato, iodrato e cloridrato, e em que o clopidogrel está na forma de partículas, grânulos ou aglomerados revestidos. Em outro aspecto, a invenção apresenta um processo para a preparação de comprimidos compreendendo clopidogrel em forma de sal farmaceuticamente aceitável, esse processo compreendendo: a) a compactação do clopidrogrel com componentes anidros ou substancialmente anidros para formar agregados, b) a desintegração dos agregados para formar grânulos ou partículas, c) opcionalmente, a misturação dos grânulos ou partículas com pelo menos um componente adicional, e d) a compactação ou compressão dos grânulos ou partículas assim formadas em comprimidos, em que o clopidogrel é usado em forma de mesilato, bromidrato, iodrato ou cloridrato, e o processo adicionalmente compreende a misturação de um seqüestrante de umidade com os agregados, grânulos ou partículas. Uma etapa de revestimento de grânulos ou partículas pode ser incluída depois da etapa b) ou da etapa c), quando presente, e antes da etapa d).
BRPI0416109-2A 2003-11-03 2004-11-03 processo para preparação de composições de clopidogrel BRPI0416109A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0325603.9A GB0325603D0 (en) 2003-11-03 2003-11-03 Organic compounds
PCT/EP2004/012437 WO2005048992A1 (en) 2003-11-03 2004-11-03 Process for preparing clopidogrel compositions

Publications (1)

Publication Number Publication Date
BRPI0416109A true BRPI0416109A (pt) 2007-01-02

Family

ID=29725839

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0416109-2A BRPI0416109A (pt) 2003-11-03 2004-11-03 processo para preparação de composições de clopidogrel

Country Status (8)

Country Link
EP (1) EP1682096A1 (pt)
JP (1) JP2007527414A (pt)
CN (1) CN101848705A (pt)
AU (1) AU2004290511A1 (pt)
BR (1) BRPI0416109A (pt)
CA (1) CA2540965A1 (pt)
GB (1) GB0325603D0 (pt)
WO (1) WO2005048992A1 (pt)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005070464A2 (en) * 2004-01-21 2005-08-04 Biofarma Ilac Sanayi Ve Ticaret A.S. A tablet formulation of clopidogrel bisulphate
JP2007533744A (ja) * 2004-04-20 2007-11-22 サノフイ−アベンテイス （＋）−（Ｓ）−α−（２−クロロフェニル）−６，７−ジヒドロチエノ［３，２−Ｃ］ピリジン−５（４Ｈ）酢酸メチル臭化水素酸塩、クロピドロゲル（ｃｌｏｐｉｄｒｏｇｅｌ）臭化水素酸塩の多形体型
BRPI0510008A (pt) 2004-04-20 2007-09-18 Sanofi Aventis sal de clopidogrel e formas polimórficas deste
US20060223845A1 (en) * 2005-02-24 2006-10-05 Eran Turgeman Clopidogrel base suitable for pharmaceutical formulation and preparation thereof
DE202005013839U1 (de) * 2005-09-01 2005-10-27 Helm Ag Pharmazeutische Formulierung für Salze monobasischer Säuren mit Clopidogrel
WO2007054968A2 (en) * 2005-09-20 2007-05-18 Torrent Pahrmaceuticals Limited Novel pharmaceutical compositions of clopidogrel mesylate
IS2385B (is) * 2006-02-10 2008-07-15 Actavis Group Hf. Klópidógrel bísúlfat lyfjasamsetningar
CZ298349B6 (cs) * 2006-03-09 2007-09-05 Zentiva, A. S Farmaceutická kompozice clopidogrelu hydrogenbromidu
JP2009532462A (ja) * 2006-04-05 2009-09-10 カディラ・ヘルスケア・リミテッド 調節放出クロピドグレル製剤
PL1847258T5 (pl) 2006-04-13 2013-06-28 Acino Pharma Ag Częściowe glicerydy jako środki poślizgowe dla kompozycji farmaceutycznych zawierających pochodne tieno[3,2-c]pirydyny
ES2337918T3 (es) * 2006-04-13 2010-04-30 Riemser Specialty Production Gmbh Poloxameros como lubricantes para composiciones farmaceuticas que contienen derivados de tieno(3,2-c)piridina.
WO2007128476A1 (en) * 2006-05-04 2007-11-15 Sandoz Ag Pharmaceutical compositions containing clopidogrel hydrochloride
KR20080055355A (ko) * 2006-12-15 2008-06-19 에스케이케미칼주식회사 보관안정성이 우수한 클로피도그렐 함유 포접 복합체
KR20080055356A (ko) * 2006-12-15 2008-06-19 에스케이케미칼주식회사 보관안정성이 우수한 클로피도그렐 함유 포접 복합체
EP1970054A3 (en) 2007-03-14 2009-06-03 Ranbaxy Laboratories Limited Clopidogrel tablets
WO2008129468A2 (en) * 2007-04-20 2008-10-30 Wockhardt Research Centre Pharmaceutical compositions of clopidogrel
PT2095815E (pt) * 2008-02-26 2012-02-03 Lesvi Laboratorios Sl Formulações farmacêuticas contendo clopidogrel
EP2107061A1 (en) 2008-04-02 2009-10-07 Krka Tovarna Zdravil, D.D., Novo Mesto Process for the preparation of optically enriched clopidogrel
ATE482961T1 (de) 2008-04-25 2010-10-15 Sandoz Ag Hydrogensulfat von 2-acetoxy-5-(a- cyclopropylcarbonyl-2-fluorbenzyl)-4,5,6,7- tetrahydrothienoä3,2-cüpyridin und dessen zubereitung
WO2010094471A1 (en) 2009-02-17 2010-08-26 Krka, D. D., Novo Mesto Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation
JP2013032289A (ja) * 2009-10-28 2013-02-14 Daiichi Sankyo Co Ltd ワックス安定製剤
ES2363964B1 (es) 2009-11-20 2012-08-22 Gp Pharm, S.A. Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados.
CN101766573B (zh) 2010-02-05 2013-02-13 上海安必生制药技术有限公司 硫酸氢氯吡格雷固体制剂的制备工艺
CN101851247B (zh) * 2010-06-04 2013-05-29 浙江华海药业股份有限公司 含有硫酸氢氯吡格雷晶体颗粒的组合物

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2363053C (en) * 2001-11-09 2011-01-25 Bernard Charles Sherman Clopidogrel bisulfate tablet formulation
WO2004074215A1 (en) * 2003-02-03 2004-09-02 Sunil Sadanand Nadkarni Process for preparation of clopidogrel, its salts and pharmaceutical compositions

Also Published As

Publication number Publication date
EP1682096A1 (en) 2006-07-26
JP2007527414A (ja) 2007-09-27
AU2004290511A1 (en) 2005-06-02
WO2005048992A1 (en) 2005-06-02
CA2540965A1 (en) 2005-06-02
CN101848705A (zh) 2010-09-29
GB0325603D0 (en) 2003-12-10

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Legal Events

Date Code Title Description
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal acc. article 33 of ipl - extension of time limit for request of examination expired